On April 29, 2024, the USA Food and Drug Administration granted full approval of the antibody drug conjugate tisotumab vedotin-tftv (Tivdak) for the treatment of recurrent or metastatic cervical cancer progressing on or after chemotherapy.
The approval was based on the global, randomized, open-label, phase 3 innovaTV 301 confirmatory trial of tisotumab vedotin vs investigator’s choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) in recurrent or metastatic cervical cancer. The study enrolled 502 patients with recurrent or metastatic cervical cancer who had received 1 or 2 previous systemic regimens, including chemotherapy with or without bevacizumab with or without an anti-PD-(L)1 therapy. Patients with active ocular surface disease, any prior episode of cicatricial conjunctivitis or ocular Stevens-Johnson syndrome, grade 2 or higher peripheral neuropathy, or clinically significant bleeding issues or risks were excluded from the study.
Median overall survival was 11.5 months with tisotumab vedotin treatment vs 9.5 months with chemotherapy (Hazard Ratio [HR]: 0.70 [95% CI: 0.54, 0.89], P = .0038). Median progression-free survival was 4.2 months with tisotumab vedotin compared with 2.9 months for those treated with chemotherapy (HR: 0.67 [95% CI: 0.54, 0.82], P < .0001). The objective response rate was 17.8% and 5.2% in the tisotumab vedotin and control arms, respectively (P < .0001).
Decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, fatigue, decreased sodium, epistaxis, and constipation were the most common adverse events.
References
1. FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer. US Food & Drug Administration. Updated April 29, 2024. Accessed April 30, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer
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